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A three-month formulation of paliperidone palmitate administered four times yearly as a long-acting injectable significantly delayed time to relapse in patients with schizophrenia compared with placebo, according to a report in JAMA Psychiatry.

Researchers with Janssen Research & Development LLC conducted a randomized, multicenter trial from April 2012 through April 2014 in eight countries. Of the 506 patients enrolled (aged 18 to 70 years; DSM-IV-TR diagnosis of schizophrenia), 305 were randomized to three-month paliperidone palmitate (n=160) or placebo (n=145).

A total of 42 patients (29 percent) in the placebo group and 14 patients (9 percent) in the group receiving three-month paliperidone palmitate experienced a relapse event. Consequently, the independent data-monitoring committee recommended early study termination for efficacy.

Paliperidone palmitate was originally formulated as a once-monthly atypical antipsychotic long-acting-injectable (LAI) and is approved for treatment of schizophrenia in adults in numerous countries. The recently developed three-month formulation offers the prospect of reducing relapse risk related to sub-therapeutic plasma concentrations and its associated negative consequences in patients with schizophrenia, the researchers noted.

“Patients randomly assigned to placebo were nearly four times more likely to relapse … than those who continued to receive three-month paliperidone palmitate,” they stated. “Patients at risk for sudden discontinuation from treatment could therefore benefit from three-month paliperidone palmitate, providing protection from relapse for up to one year after the last dose.”